Let’s protect all infants against Respiratory Syncytial Virus (RSV) given newly available immunization solutions


Respiratory Syncytial Virus (RSV) is the most common cause of lower respiratory tract infections (LRTIs), including bronchiolitis and pneumonia in infants (Plotkin SA, 2018). It is also a leading driver of hospitalization in all infants, with most hospitalizations for RSV occurring in healthy infants born at term; as such, the seasonal epidemic has a considerable public health impact every year (Hall C, 2013), also including outpatient visits and emergency department consultations, for which antibiotics are frequently prescribed. Globally, it is estimated that RSV causes a substantial health burden for infants below 12 months of age, with 12.9 million of RSV LRTI episodes, 2.2 million hospitalizations and 66,300 deaths in 2019 (Li Y, 2022), not to mention the burden related to additional RSV-related complications, such as acute otitis media (EHMA, 2022). 

To address the burden of RSV, the World Health Organization is encouraging unprecedented research efforts to find innovative immunization solutions, including monoclonal antibodies (mAbs) and vaccines for use in pregnant women and paediatric populations (WHO, 2021). Until now, there has been no prophylactic solution to prevent RSV among all infants, only a mAb for restricted use in selected populations of infants and young children with underlying conditions (WHO, 2021). After decades of research, new RSV immunization solutions are becoming available. On 31st October 2022, the European Commission approved Beyfortus® (nirsevimab) for the prevention of RSV lower respiratory tract disease in newborns and infants during their first RSV season (Sanofi, 2022). Beyfortus® (nirsevimab) is the first preventive solution for the broad infant population, including those born healthy, at term or preterm, or with specific health conditions. Further new immunization solutions against RSV are likely to become available in the upcoming years and in the near future, these may offer the promise of making RSV a preventable disease in all infants (PATH, 2022). 

With the recent approval of new immunization solutions against RSV, several national immunization agencies are starting to develop recommendations for RSV prevention, encompassing not only traditional vaccines but also newer immunization technologies such as preventative RSV mAbs, which confer passive immunization. In the UK, a subcommittee is being established to review these new products and advise on their potential use in the National Immunisation Program (NIP) (Parliament & Baroness Ritchie, 2022), while in the US, the Advisory Committee on Immunization Practices (ACIP) has also begun to consider providing recommendations on the use of specific antibody products for prevention of infectious diseases (CDC, 2022). 

An all-infant immunization program, as soon as it is cost-effective, would be the most efficient tool to secure high uptake and significantly reduce the RSV burden and alleviate healthcare systems by reducing the economic burden on hospitals, emergency departments and outpatient care. Therefore, it is critical that national immunization technical advisory committees (NITAGs) and medical societies continue to assess how these solutions can be made available and how they may be applicable in the field to all infants as soon as possible. 

It is key that appropriate policy recommendations are in place to support the inclusion of upcoming RSV immunization solutions for broad populations, encompassing both mAbs and vaccines, in the routine immunization calendar. In addition, a well-prepared and coordinated implementation program must be established, and a broad range of professionals needs to be engaged to secure access for all infants and alleviate the significant burden that RSV represents for infants, families and healthcare systems.